The following data is part of a premarket notification filed by Beijing Choice Electronic Technology Co., Ltd. with the FDA for Infrared Thermometer.
| Device ID | K211752 |
| 510k Number | K211752 |
| Device Name: | Infrared Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Beijing Choice Electronic Technology Co., Ltd. 2nd Floor 3rd Floor And Room 410-412 4th Floor No. 2 Building No. 9 Shuangyuan Road Shijingshan Beijing, CN 100041 |
| Contact | Haiying Zhao |
| Correspondent | Haiying Zhao Beijing Choice Electronic Technology Co., Ltd. 2nd Floor 3rd Floor And Room 410-412 4th Floor No. 2 Building No. 9 Shuangyuan Road Shijingshan Beijing, CN 100041 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-07 |
| Decision Date | 2022-01-21 |